Subjective Cognitive ComplaintsEMMANCT05696756
Electronic Memory and Management Aid
A study testing Personalized Web-based training for EMMA app and Motivational Interviewing: Clinician Support in people with Subjective Cognitive Complaints and Mild Cognitive Impairment, run by Washington State University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a personalized, web-based training intervention that was developed to teach use of an Electronic Memory and Management Aid (EMMA) application. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjective Cognitive Complaints, Mild Cognitive Impairment
- What is being tested?
- Personalized Web-based training for EMMA app and Motivational Interviewing: Clinician Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be age 50 or older
- Self-reporting subjective cognitive complaints (screening questions)
- Must be able to read and speak English
Who cannot join
- Cannot provide own informed consent
- Have a known medical, neurological or psychiatric diagnosis that explains current cognitive complaints (e.g., stroke)
- Cannot complete remote study protocol due to severe vision or hearing difficulties
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington State University - Pullman; Study Remote
Pullman, Washington, 99164-4820
Magaret Dines, B.S., 509-335-4033, margaret.dines@wsu.edu
Maureen Schmitter-Edgecombe, PhD, 1-509-335-0170, schmitter-e@wsu.edu
About this study
Official title: Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties
This study will evaluate the effectiveness of a personalized, web-based training intervention that was developed to teach use of an Electronic Memory and Management Aid (EMMA) application. The app-based system is designed to support everyday memory, daily activity management and positive health behavior engagement for older adults with subjective cognitive complaints or mild cognitive impairment. The investigators will also evaluate the degree to which a clinician is needed to oversee the uptake and utilization of the EMMA app during the web-based training intervention.
Read the detailed description
Participants will be randomly assigned to one of two groups, "Technical Support Only" group (T-only group) and "Technical + Clinician Support" group (T+C group). Participants will be enrolled in the study for 6 months.
Participants who pass initial phone screening criteria will participate in a 2-3 hour neurocognitive assessment over zoom to establish baseline cognition, prior to beginning the intervention. Participants will also complete questionnaires and a real-world measure assessing daily functioning. After the initial assessment is complete, participants will be given one-month to learn to use the EMMA app by completing the self-paced intervention via the adaptive, web-based training platform, which includes six lessons. EMMA device-use will be captured throughout the study by the app itself.
A component of the self-paced, web-based intervention involves setting goals related to using the EMMA app. A clinician will monitor the training data and goals the T+C group participants make and conduct brief problem-solving and goal-refining sessions during the intervention weeks. These sessions are expected to be 10-15 minutes. To keep training on track, the T-only group will receive brief phone check-ins to monitor progression through the web-based intervention. Following training, there will no longer be any differences in the treatment of both groups, which will be monitored for an additional three months. Immediately following training and at the end of the 3 month monitoring period, all participants will complete the battery of questionnaires and answer a semi-structured phone interview. In addition, at the end of the 3 month follow-up, all participants will again complete the neurocognitive assessment and real-world measure of daily functioning.
- Being tested
- Personalized Web-based training for EMMA app, Motivational Interviewing: Clinician Support
- Keywords
- activities of daily living, memory, electronic aid, quality of life, health, time management
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Web-based training for EMMA appBehavioural
Participants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform.
Motivational Interviewing: Clinician SupportBehavioural
Participants will receive weekly brief check-ins with clinicians to motivate and support the problem-solving and habit formation aspects of the web-based training.
| Study group | Role | What they receive |
|---|---|---|
| Brief Clinician Motivational Support | Experimental | Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician. Receives: Behavioral: Personalized Web-based training for EMMA app; Behavioral: Motivational Interviewing: Clinician Support |
| Technology Support Only | Active comparator | Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed. Receives: Behavioral: Personalized Web-based training for EMMA app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EMMA app use daily interactions
Total daily use interactions derived from the EMMA app will provide a measure of how much the app is being used.
Measured: continuous data collection through study completion up to 6 months
Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)
To measure participants capacity to complete instrumental activities of daily living (IADLs) at home, participants complete a series of brief tasks that resemble typical IADLs (e.g., paying utility bills, running errands, filling out a rebate form) six days a week for three weeks (total score; range 0-93; higher scores indicate better performance).
Measured: at baseline and 6 month follow-up
Change in Cognitive Self-efficacy Questionnaire (CSEQ)
Self-report measure of a participants confidence in their everyday cognitive abilities (mean score; range 0-10; higher scores represent better self-reported confidence in cognitive abilities).
Measured: at baseline, immediately post-training and 6 month follow-up
Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)
Self-report measure assessing a participants mental and physical health (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology)
Measured: at baseline, immediately post-training and 6 month follow-up
Secondary outcomes (4)
Change in Coping Self-efficacy Scale (CSES)
Self-report measure of coping abilities (total score; range 1-130; higher scores represent greater self-perceived coping abilities)
Measured: at baseline, immediately post-training and 6 month follow-up
Change in Everyday Compensation questionnaire (Ecomp)
Self-report of everyday compensatory strategy use (mean score; range 0-4; higher scores represent better self-reported use of everyday compensatory strategies).
Measured: at baseline, immediately post-training and 6 month follow-up
Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition
Self-perception of cognitive abilities (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology).
Measured: at baseline, immediately post-training and 6 month follow-up
Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Self-perception of medication management abilities (total score, range 13-39, higher scores are associated with greater self-efficacy for adherence to medications)
Measured: at baseline, immediately post-training and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Maureen-Schmitter-Edgecombe, Washington State University
- Investigators
- Maureen Schmitter-Edgecombe, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696756
- Sponsor's protocol ID
- AZ190055
- Acronym
- EMMA
- Status last verified
- Jan 2023
- First submitted
- 23 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can request use of data
Publications
Schmitter-Edgecombe M, Luna C, Chilton RC, Rahman S, Beech BF, Li X, Dines M, Dai S, Cook DJ. Promoting digital memory aid use in older adults with cognitive concerns: A pilot randomized controlled trial of adaptive web-based training. Neuropsychology. 2026 Apr 27. doi: 10.1037/neu0001071. Online ahead of print.
PubMed 42043435
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties
- ClinicalTrials.gov ID
- NCT05696756
- Acronym / sponsor ID
- EMMA / AZ190055
- Keywords
- activities of daily living, memory, electronic aid, quality of life, health, time management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a personalized, web-based training intervention that was developed to teach use of an Electronic Memory and Management Aid (EMMA) application. The app-based system is designed to support everyday memory, daily activity management and positive health behavior engagement for older adults with subjective cognitive complaints or mild cognitive impairment. The investigators will also evaluate the degree to which a clinician is needed to oversee the uptake and utilization of the EMMA app during the web-based training intervention.
Detailed description
Participants will be randomly assigned to one of two groups, "Technical Support Only" group (T-only group) and "Technical + Clinician Support" group (T+C group). Participants will be enrolled in the study for 6 months.
Participants who pass initial phone screening criteria will participate in a 2-3 hour neurocognitive assessment over zoom to establish baseline cognition, prior to beginning the intervention. Participants will also complete questionnaires and a real-world measure assessing daily functioning. After the initial assessment is complete, participants will be given one-month to learn to use the EMMA app by completing the self-paced intervention via the adaptive, web-based training platform, which includes six lessons. EMMA device-use will be captured throughout the study by the app itself.
A component of the self-paced, web-based intervention involves setting goals related to using the EMMA app. A clinician will monitor the training data and goals the T+C group participants make and conduct brief problem-solving and goal-refining sessions during the intervention weeks. These sessions are expected to be 10-15 minutes. To keep training on track, the T-only group will receive brief phone check-ins to monitor progression through the web-based intervention. Following training, there will no longer be any differences in the treatment of both groups, which will be monitored for an additional three months. Immediately following training and at the end of the 3 month monitoring period, all participants will complete the battery of questionnaires and answer a semi-structured phone interview. In addition, at the end of the 3 month follow-up, all participants will again complete the neurocognitive assessment and real-world measure of daily functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Clinician Motivational Support | Experimental | Behavioral: Personalized Web-based training for EMMA app, Behavioral: Motivational Interviewing: Clinician SupportParticipants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician. |
| Technology Support Only | Active comparator | Behavioral: Personalized Web-based training for EMMA appParticipants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be age 50 or older
- Self-reporting subjective cognitive complaints (screening questions)
- Must be able to read and speak English
Key exclusion criteria (3 listed)
- Cannot provide own informed consent
- Have a known medical, neurological or psychiatric diagnosis that explains current cognitive complaints (e.g., stroke)
- Cannot complete remote study protocol due to severe vision or hearing difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Web-based training for EMMA appParticipants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform. | Behavioural | Brief Clinician Motivational Support, Technology Support Only |
| Motivational Interviewing: Clinician SupportParticipants will receive weekly brief check-ins with clinicians to motivate and support the problem-solving and habit formation aspects of the web-based training. | Behavioural | Brief Clinician Motivational Support |
Primary outcome
Change in EMMA app use daily interactions
Time frame: continuous data collection through study completion up to 6 months
Total daily use interactions derived from the EMMA app will provide a measure of how much the app is being used.
Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)
Time frame: at baseline and 6 month follow-up
To measure participants capacity to complete instrumental activities of daily living (IADLs) at home, participants complete a series of brief tasks that resemble typical IADLs (e.g., paying utility bills, running errands, filling out a rebate form) six days a week for three weeks (total score; range 0-93; higher scores indicate better performance).
Change in Cognitive Self-efficacy Questionnaire (CSEQ)
Time frame: at baseline, immediately post-training and 6 month follow-up
Self-report measure of a participants confidence in their everyday cognitive abilities (mean score; range 0-10; higher scores represent better self-reported confidence in cognitive abilities).
Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)
Time frame: at baseline, immediately post-training and 6 month follow-up
Self-report measure assessing a participants mental and physical health (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology)
4 secondary outcomes
Change in Coping Self-efficacy Scale (CSES)
Time frame: at baseline, immediately post-training and 6 month follow-up
Change in Everyday Compensation questionnaire (Ecomp)
Time frame: at baseline, immediately post-training and 6 month follow-up
Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition
Time frame: at baseline, immediately post-training and 6 month follow-up
Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Time frame: at baseline, immediately post-training and 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 42043435Schmitter-Edgecombe M, Luna C, Chilton RC, Rahman S, Beech BF, Li X, Dines M, Dai S, Cook DJ. Promoting digital memory aid use in older adults with cognitive concerns: A pilot randomized controlled trial of adaptive web-based training. Neuropsychology. 2026 Apr 27. doi: 10.1037/neu0001071. Online ahead of print.
- Individual participant dataSharing planned: No. Other researchers can request use of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Schmitter-Edgecombe, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Web-based training for EMMA app and Motivational Interviewing: Clinician Support in people with Subjective Cognitive Complaints and Mild Cognitive Impairment, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie Dines, B.S. (1-509-335-4033, margaret.dines@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EMMA app use daily interactions (time frame: continuous data collection through study completion up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.